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Serving hundreds of leading biopharmaceutical companies globally:

Citi
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Cantor Fitzgerald
AstraZeneca
McKesson
UBS
Dow
Deloitte
Fuji

Generated: August 17, 2018

DrugPatentWatch Database Preview

VISTOGARD Drug Profile

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Which patents cover Vistogard, and what generic alternatives are available?

Vistogard is a drug marketed by Wellstat Therap and is included in one NDA. There are two patents protecting this drug.

This drug has one hundred and seventy-five patent family members in twenty-one countries.

The generic ingredient in VISTOGARD is uridine triacetate. There are thirty-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the uridine triacetate profile page.

Summary for VISTOGARD
International Patents:175
US Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Formulation / Manufacturing:see details
DailyMed Link:VISTOGARD at DailyMed
Drug patent expirations by year for VISTOGARD
Generic Entry Opportunity Date for VISTOGARD
Generic Entry Date for VISTOGARD*:
Constraining patent/regulatory exclusivity:
EMERGENCY TX OF PTS FOLLOWING A FU OR CAPECITABINE OD, OR WHO EXHIBIT EARLY-ONSET, SEVERE OR LIFE-THREATENING TOXICITY AFFECTING THE CARDIAC SYSTEM OR CNS, AND/OR EARLY-ONSET, UNUSUALLY SEVERE AR W/IN 96 HRS FOLLOWING THE END OF FU OR CAPECITABINE ADMIN.
NDA:
Dosage:
GRANULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for VISTOGARD

US Patents and Regulatory Information for VISTOGARD

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Wellstat Therap VISTOGARD uridine triacetate GRANULE;ORAL 208159-001 Dec 11, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Wellstat Therap VISTOGARD uridine triacetate GRANULE;ORAL 208159-001 Dec 11, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Wellstat Therap VISTOGARD uridine triacetate GRANULE;ORAL 208159-001 Dec 11, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Wellstat Therap VISTOGARD uridine triacetate GRANULE;ORAL 208159-001 Dec 11, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Wellstat Therap VISTOGARD uridine triacetate GRANULE;ORAL 208159-001 Dec 11, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for VISTOGARD

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,173,017 Pyrimidine nucleotide precursors for treatment of systemic inflammation and inflammatory hepatitis ➤ Try a Free Trial
5,770,582 Pharmaceutical compositions containing deoxyribonucleosides for wound healing ➤ Try a Free Trial
7,105,498 Acylated uridine and cytidine and uses thereof ➤ Try a Free Trial
6,344,447 Treatment of chemotherapeutic agent and antiviral agent toxicity with acylated pyrimidine nucleosides ➤ Try a Free Trial
7,307,166 Oxpurine nucleosides and their congeners, and acyl, derivatives thereof, for improvement of hematopoiesis ➤ Try a Free Trial
6,297,222 Acyl deoxyribonucleoside derivatives and uses thereof ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents for VISTOGARD

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO) 9604923 ➤ Try a Free Trial
South Africa 8902928 ➤ Try a Free Trial
Norway 317199 ➤ Try a Free Trial
Japan 2003201240 ➤ Try a Free Trial
Russian Federation 2158269 ➤ Try a Free Trial
Australia 1417792 ➤ Try a Free Trial
Country Document Number Estimated Expiration

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Supplementary Protection Certificates for VISTOGARD

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0889 Netherlands ➤ Try a Free Trial PRODUCT NAME: TRIFLURIDINE IN COMBINATIE MET TIPIRACILHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/16/1096 20160427
2017 00036 Denmark ➤ Try a Free Trial PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL OR A PHARMACEUTICALLY ACCEPTABLE SALT OF TIPIRACIL; REG. NO/DATE: EU/1/16/1096 20160427
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Healthtrust
Fuji
McKesson
Covington
Moodys
Harvard Business School
Argus Health
Chinese Patent Office

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